Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2022-06-30

Brief Summary

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Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. End tidal CO2 detectors (ETCO2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change.

This is a trial evaluating the use of a qualitative end tidal CO2 monitor device during mask ventilation in the delivery room. The investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.

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Detailed Description

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Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monitor

Qualitative End Tidal Co2 detector will be attached to the face mask used to provide mask ventilation to the preterm baby before connected to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume.

Group Type EXPERIMENTAL

Monitor Group

Intervention Type DEVICE

Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths

Control

face mask used to provide mask ventilation to the preterm baby will be connected directly to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Monitor Group

Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation

Exclusion Criteria

1. Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
2. Infants with congenital airway anomalies

Maximum Eligible Age

60 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes